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FOWLER ENDOCURETTE, MODEL CUR-XXX

K000974 Class II Traditional
Decision Date
2000-05-23
Sponsor / Applicant
Utah Medical Products, Inc.

Technical Specification

510(k) Submission ID K000974
Product Code HHK
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.1175
Decision Date 2000-05-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

FOWLER ENDOCURETTE, MODEL CUR-XXX received FDA 510(k) clearance under submission number K000974, sponsored by Utah Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-05-23.

Classification & Regulation

This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.